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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5172-079 | Other Identifier | Merck Protocol Number | |
| 2015-003006-16 | EudraCT Number |
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The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and grazoprevir [GZR] 100 mg) and EBR/GZR (varying doses) pediatric granules in pediatric hepatitis C virus (HCV)-infected participants who are 3 to <18 years of age. Within each age cohort (Cohort 1: 12 to <18 years of age; Cohort 2: 7 to <12 years of age; and Cohort 3: 3 to <7 years of age), a Mini Cohort of 7 participants will be enrolled first. For the oldest cohort (Cohort 1), the Mini Cohort will assess ability to swallow a placebo tablet prior to administering active FDC tablets; participants in Cohorts 2 and 3 will take pediatric granules instead of a tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBR/GZR | Experimental | Pediatric participants receive EBR/GZR as either FDC tablets or oral granules once daily for 12 weeks. A 24-week follow-up period will follow the 12-week treatment regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBR/GZR FDC Tablet | Drug | Participants who are 12 to <18 years of age will receive oral FDC tablets with EBR 50 mg/GZR 100 mg once daily by mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State | The AUC0-24hr of EBR at steady state (Week 4) was determined in each cohort. | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| Maximum Plasma Concentration (Cmax) of EBR | The Cmax of EBR at steady state (Week 4) was determined in each cohort. | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| Steady State Predose Drug Concentration (Ctrough) of EBR | The Ctrough of EBR at steady state (Week 4) was determined at steady state prior to dosing in each cohort. | Week 4: Predose |
| Apparent Clearance (CL/F) of EBR at Steady State | The CL/F of EBR at steady state (Week 4) was determined in each cohort. | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| AUC0-24hr of GZR at Steady State | The AUC0-24hr of GZR at steady state (Week 4) was determined in each cohort. | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| Cmax of GZR | The Cmax of GZR at steady state (Week 4) was determined in each cohort. | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| Ctrough of GZR | The Ctrough of GZR at steady state (Week 4) was determined at steady state prior to dosing in each cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥1 Adverse Event (AE) | The percentage of participants with ≥1 AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco ( Site 0020) | San Francisco | California | 94158 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36790337 | Result | Gonzalez-Peralta RP, Wirth S, Squires RH, Mutschler F, Lang T, Pawlowska M, Sluzewski W, Majda-Stanislawska E, Fischler B, Balistreri WF, Jonas MM, Blondet N, Rosenthal P, Alkhouri N, Romero R, Grandhi A, Castronuovo P, Caro L, Du L, Rosenbloom DIS, Haber BA. Elbasvir/grazoprevir in children aged 3-18 years with chronic HCV genotype 1 or 4 infection: a pharmacokinetic modeling study. Hepatol Commun. 2023 Feb 14;7(3):e0031. doi: 10.1097/HC9.0000000000000031. eCollection 2023 Mar 1. |
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Male and female participants 3 to <18 years of age with chronic hepatitis C virus (HCV) genotype 1 (GT1) or GT4 were enrolled at 14 global study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Pediatric participants 12 to <18 years of age received elbasvir (EBR) 50 mg / grazoprevir (GZR) 100 mg fixed dose combination (FDC) tablets once daily for 12 weeks. |
| FG001 | Age Cohort 2: 7 to <12 Years: Mini and Expanded |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2018 |
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| Placebo | Drug | Placebo tablet matched to EBR/GZR FDC tablet. |
|
| Grazoprevir Oral Granules | Drug | Participants 3 to <12 years of age take grazoprevir granules 0.5 mg by mouth in a soft food vehicle at a dose not to exceed 50 mg. |
|
|
| Elbasvir Oral Granules | Drug | Participants 3 to <12 years of age take elbasvir oral granules 1 mg by mouth in a soft food vehicle at a dose not to exceed 100 mg. |
|
|
| Week 4: Predose |
| CL/F of GZR at Steady State | The CL/F of GZR at steady state (Week 4) was determined in each cohort. | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| Percentage of Participants Discontinuing Study Treatment Due to an AE |
The percentage of participants discontinuing study therapy due to an AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
| Up to 12 weeks |
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12) | The percentage of participants achieving SVR12, defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after completing study therapy, was determined in each cohort. | Week 24 |
| Florida Hospital ( Site 0006) |
| Orlando |
| Florida |
| 32803 |
| United States |
| Children's Center for Advanced Pediatrics ( Site 0204) | Atlanta | Georgia | 30329 | United States |
| Children's Hospital Boston ( Site 0009) | Boston | Massachusetts | 02115 | United States |
| Cincinnati Children's Hospital Medical Center ( Site 0003) | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Pittsburgh ( Site 0024) | Pittsburgh | Pennsylvania | 15224 | United States |
| American Research Corporation ( Site 0200) | San Antonio | Texas | 78215 | United States |
| Children's Hospital and Regional Medical Center ( Site 0017) | Seattle | Washington | 98105 | United States |
| Medizinische Hochschule Hannover Kinderklinik K10 ( Site 0105) | Hanover | 30625 | Germany |
| Klinikum Starnberg ( Site 0107) | Starnberg | 82319 | Germany |
| Helios Klinikum Wuppertal GmbH ( Site 0104) | Wuppertal | 42283 | Germany |
| WSOZ im.T.Browicza w Bydgoszczy ( Site 0800) | Bydgoszcz | 85-030 | Poland |
| Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 0810) | Lodz | 91-347 | Poland |
| MED-POLONIA Sp. z o.o. ( Site 0808) | Poznan | 60-693 | Poland |
| Karolinska Universitetssjukhuset Huddinge. ( Site 0062) | Stockholm | 141 86 | Sweden |
Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks. |
| FG002 | Age Cohort 3: 3 to <7 Years: Mini | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg. |
| FG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Age Cohort 1: 12 to <18 Years: Mini and Expanded | Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks. |
| BG001 | Age Cohort 2: 7 to <12 Years: Mini and Expanded | Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks. |
| BG002 | Age Cohort 3: 3 to <7 Years: Mini | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg. |
| BG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State | The AUC0-24hr of EBR at steady state (Week 4) was determined in each cohort. | All randomized and treated participants who complied with the protocol sufficiently to ensure that their pharmacokinetic (PK) data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included. | Posted | Geometric Mean | 95% Confidence Interval | µM*hr | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Maximum Plasma Concentration (Cmax) of EBR | The Cmax of EBR at steady state (Week 4) was determined in each cohort. | All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included. | Posted | Geometric Mean | 95% Confidence Interval | µM | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Steady State Predose Drug Concentration (Ctrough) of EBR | The Ctrough of EBR at steady state (Week 4) was determined at steady state prior to dosing in each cohort. | All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included. One participant in Age Cohort 2: 7 to <12 Years: Mini and Expanded had missing Ctrough data. | Posted | Geometric Mean | 95% Confidence Interval | nM | Week 4: Predose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Apparent Clearance (CL/F) of EBR at Steady State | The CL/F of EBR at steady state (Week 4) was determined in each cohort. | All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included. | Posted | Geometric Mean | 95% Confidence Interval | L/hr | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ≥1 Adverse Event (AE) | The percentage of participants with ≥1 AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | All randomized participants who received ≥1 dose of study drug are included. | Posted | Number | Percentage of Participants | Up to 36 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Discontinuing Study Treatment Due to an AE | The percentage of participants discontinuing study therapy due to an AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | All randomized participants who received ≥1 dose of study drug are included. | Posted | Number | Percentage of Participants | Up to 12 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12) | The percentage of participants achieving SVR12, defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after completing study therapy, was determined in each cohort. | All randomized participants who received ≥1 dose of study treatment are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Primary | AUC0-24hr of GZR at Steady State | The AUC0-24hr of GZR at steady state (Week 4) was determined in each cohort. | All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included. | Posted | Geometric Mean | 95% Confidence Interval | µM*hr | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Cmax of GZR | The Cmax of GZR at steady state (Week 4) was determined in each cohort. | All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included. | Posted | Geometric Mean | 95% Confidence Interval | µM | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Ctrough of GZR | The Ctrough of GZR at steady state (Week 4) was determined at steady state prior to dosing in each cohort. | All randomized and treated participants who complied with the protocol sufficiently to ensure that their PK data was likely to exhibit the effects of treatment, according to the underlying scientific model, are included. One participant in Age Cohort 2: 7 to <12 Years: Mini and Expanded had missing Ctrough data. | Posted | Geometric Mean | 95% Confidence Interval | nM | Week 4: Predose |
| ||||||||||||||||||||||||||||||||||||
| Primary | CL/F of GZR at Steady State | The CL/F of GZR at steady state (Week 4) was determined in each cohort. | No participants are included in the analysis as the CL/F of GZR was not calculable due to nonlinear PK. | Posted | Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose |
|
Up to 36 weeks for nonserious AEs (NSAEs) and serious AEs (SAEs), and up to approximately 49 weeks for all-cause mortality.
All participants who received ≥1 dose of study drug are included. All-cause mortality is based on all randomized participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Age Cohort 1: 12 to < 18 Years | Pediatric participants 12 to <18 years of age received EBR/GZR 50 mg/100 mg FDC tablets once daily for 12 weeks. | 0 | 22 | 1 | 22 | 17 | 22 |
| EG001 | Age Cohort 2: 7 to < 12 Years | Participants who are 7 to <12 years of age received EBR/GZR 30 mg/60 mg pediatric granules once daily for 12 weeks. | 0 | 17 | 0 | 17 | 13 | 17 |
| EG002 | Age Cohort 3 Mini: 3 to < 7 Years | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR (weight-based dosing) once daily for 12 weeks. The Mini cohort consists of the first 7 participants enrolled into Age Cohort 3. Participants <20 kg received EBR/GZR 15 mg/30 mg, and participants ≥20 kg received EBR/GZR 15 mg/50 mg. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG003 | Age Cohort 3 Expanded: 3 to < 7 Years | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. | 0 | 11 | 1 | 11 | 9 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Energy increased | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Behaviour disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Provisional tic disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
The results of this study may be published or presented at scientific meetings. The sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jul 29, 2020 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000611265 | elbasvir-grazoprevir drug combination |
| C578009 | grazoprevir |
| C000589335 | elbasvir |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
|
|
| OG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
|
|
| OG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
|
|
| OG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
|
|
| OG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
|
|
| OG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
|
|
| OG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
|
|
| OG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
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| OG003 | Age Cohort 3: 3 to <7 Years: Expanded | Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
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Participants who are 3 to <7 years of age received a pediatric formulation of EBR/GZR 25 mg/50 mg once daily for 12 weeks. The Expanded cohort consists of 11 participants enrolled after the Mini Cohort of 7 participants. |
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